Role of Early Cardiac Catheterization in Cardiac Arrest
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).
研究概览
简要总结
This is a pilot study that will lead to a large randomized control trial (RCT), to assess whether early versus late or no cardiac catheterization is associated with improved outcomes in out-of-hospital cardiac arrest (OHCA) patients.
详细描述
A pilot multicenter RCT.
The objectives of the study are:
To assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.
Patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glasgow Coma Scale score <8 on hospital admission following OHCA of presumed cardiac cause.
- •Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for >20 consecutive minutes
排除标准
- •ST-elevation on any of the ECGs post resuscitation
- •Hypothermia <30°C
- •Interval from ROSC to screening of >12h
- •Suspected or known acute intracranial hemorrhage or stroke
研究组 & 干预措施
Early cardiac catheterization
Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia
干预措施: Cardiac catheterization (Procedure)
Medical arm
Initial therapy does not include cardiac catheterization. Cardiac catheterization with possible PCI is allowed after completion of mild therapeutic hypothermia or apyrexia for >24h post ROSC.
结局指标
主要结局
Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).
时间窗: 30 days
次要结局
- Composite of death and poor neurologic outcome(1 year)
- Death(30 day)
- CPC score(up to 30 days)
- Bleeding - according to Hb levels(30 days)
- Stent thrombosis by pathology or angiography(30 days)
- Acute kidney injury- creatinine levels(48 hours)
- Myocardial infarction - according to cardiac troponin levels(30 days)
- Stroke - imaging or pathology(30 days)
- Heart failure (NYHA 3-4)(30 days)
- Estimated cost per patient according to length of stay and procedures performed(30 days)
研究者
Shahar Lavi
Principal Investigator
Lawson Health Research Institute